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  • FDA Expands List of Harmful Tobacco Constituents

    FDA Expands List of Harmful Tobacco Constituents

    The U.S. Food and Drug Administration announced that it finalized the addition of 18 chemicals to its list of Harmful and Potentially Harmful Constituents (HPHCs), bringing the total to 111 substances identified in tobacco products, smoke, or aerosol. The list is intended to highlight compounds that pose known or potential risks to human health and applies across cigarette, e-cigarette, cigar, and hookah tobacco product categories.

    The newly added constituents include a range of flavoring agents, solvents, and byproducts, many of which are commonly associated with e-liquid formulations. FDA said the update provides greater transparency for the public while also signaling to manufacturers which chemicals may receive increased scrutiny during the review of new product applications. The agency emphasized that inclusion on the HPHC list does not constitute a ban, but triggers reporting requirements under the Federal Food, Drug, and Cosmetic Act.

    The agency also opened a new consultation on three additional compounds—pulegone, furfuryl alcohol, and methyl eugenol—frequently used as flavoring ingredients, with public comments due by May 26. In addition, FDA confirmed that respiratory toxicants identified by the National Institute for Occupational Safety and Health (NIOSH) will now be considered as a criterion for future additions to the list. The agency said it expects to continue updating the HPHC list as new scientific evidence emerges.

    The constituents added to the Register are: Acetic Acid, Acetoin (also known as 3-hydroxy-2-butanone), Acetyl Propionyl (also known as 2,3-pentanedione), Benzyl Acetate, Butyraldehyde, Diacetyl, Diethylene Glycol, Ethyl Acetate, Ethylene Glycol, Furfural, Glycerol, Glycidol, Isoamyl Acetate, Isobutyl Acetate, Methyl Acetate, n-Butanol, Propionic Acid, and Propylene Glycol.

  • ATNF Panel Examines State-Level Policy Challenges for Harm Reduction

    ATNF Panel Examines State-Level Policy Challenges for Harm Reduction

    At the American Tobacco and Nicotine Forum (ATNF), a panel moderated by Beth Oliva, a partner at Fox Rothschild, brought together industry, policy, and regulatory experts to examine how state and local policymaking is shaping harm reduction. Panelists Dr. Jeff Willett from the Progressive Policy Institute, Sarah McQuillan from JTI Liggett, Andrew Nunes from PwC, and Laura Leigh Oyler from Haypp Group, repeatedly emphasized a core issue: a widespread lack of understanding among state lawmakers about federal tobacco regulation and the FDA’s role. Several speakers noted that policymakers are often making decisions without a clear grasp of existing frameworks, definitions, or scientific standards, contributing to fragmented and sometimes contradictory regulations.

    A major theme was the disconnect between data and policymaking. Panelists pointed to declining cigarette use alongside growth in alternative products, yet said state responses are often driven more by headlines than evidence. Willett highlighted progress in reducing youth vaping since 2019 and stressed the importance of fact-based policy, while others noted that tax increases, flavor bans, and regulatory gaps can unintentionally push consumers toward illicit markets or cross-border purchases. Nunes and Oyler both underscored how inconsistent tax structures and regulatory approaches across states are distorting markets and complicating compliance for manufacturers and retailers.

    The panel also focused heavily on the growth of illicit markets, with speakers linking it to unmet consumer demand and regulatory gaps. Oyler argued that the lack of authorized products has created a “vacuum” filled by unregulated alternatives, while Willett pointed to evidence that high taxes and restrictions are driving illicit sales in markets like New York. Broader inconsistencies—such as stricter rules for nicotine compared to cannabis or alcohol—were cited as further complicating enforcement and public perception. Panelists warned that states are increasingly reliant on tobacco tax revenue, which can influence policy decisions, and called for more coordinated, evidence-based approaches rather than a patchwork of state-by-state rules.

    Finally, the discussion turned to communication and public health messaging. Speakers argued that the current narrative around nicotine lacks nuance, with limited recognition of the continuum of risk or the role of reduced-risk products. Several panelists called for the FDA to take a more active role in educating both lawmakers and the public, while also stressing the need for better data to be incorporated into legislative debates. Without improved communication and alignment between federal science and state policy, the panel suggested that regulatory fragmentation and market distortions are likely to persist.

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  • 7th Circuit Upholds Wisconsin Ban on Unauthorized Vape Sales

    7th Circuit Upholds Wisconsin Ban on Unauthorized Vape Sales

    The U.S. Court of Appeals for the Seventh Circuit has ruled that federal law does not preempt Wisconsin’s authority to ban the sale of e-cigarettes that lack FDA authorization, allowing the state to continue enforcing its restrictions. The decision rejects arguments from vaping industry groups that federal tobacco regulations should override state-level controls on product sales and marketing.

    The court found that while the FDA regulates tobacco products at the federal level, states retain the power to impose their own rules on how such products are sold within their borders. The ruling reinforces the ability of states to take independent action against unauthorized vaping products, particularly those that have not received marketing authorization from the FDA.

  • Panel: From Pilot to Progress in Product Authorizations

    Panel: From Pilot to Progress in Product Authorizations

    The panel on the FDA’s nicotine pouch pilot program, moderated by Roxana Weil from McKinney Specialty Labs, was a great discussion between the FDA’s Cristi Stark, Reynolds American’s Carolina Garcia-Canton, Altria Client Service’s Sydana Rogers Hollins, and Kleinfeld, Kaplan, and Becker’s Stacy Ehrlich about the status of the pilot program and what both the FDA and the industry have learned from in the process.

    The pouch pilot program was introduced in 2025, and according to Stark, it started with four applicants and is ending with the same four applicants. She stated that the program aimed for more communication and that the program started at filing. Stark noted that one of the biggest changes the FDA made in the pilot program versus the normal authorization pathway was that the regulatory body followed up with the four pilot companies via email rather than just the more formal letters. The panel participants all noted that the use of email communication was a huge benefit because it allowed for more communication, and more informal communication that helped them to get a better understanding of what the FDA is looking for in their applications.

    One of the biggest points of discussion and agreement was that the pilot program has been successful in creating better lines of communication between the FDA and the industry when it comes to market authorization applications and what is expected and needed to help move the review process along and get product authorized. According to Garcia-Canton, the biggest success has been communication, not necessarily increasing the speed of the review process. Ehrlich agreed that the communication was much better but stated that the FDA needs to be substantially more transparent.

    A point of contention has always been that applicants and the industry feel that the FDA takes too long to review products—the process has taken much longer than the stated 180 days. Ehrlich stated that the process timing needs to be equal for the applicants and the regulatory body; the FDA takes lots of time to review the applications, but companies aren’t necessarily given the time they need to address issues. Stark’s response to the amount of time the process takes was to lay out the process the organization goes through and to emphasize utilizing the pre-submission process and meetings to avoid running into things like timing issues, especially for small companies as they may not have the resources or time to complete longer studies that the FDA may request.

    In discussing the differences in the pilot program versus the normal submission process, Rogers Hollins noted that the FDA’s engagement and tone in the pilot program has been “super helpful and impactful.” She noted that communicating via email was very different than her previous experience with the FDA and that it was helpful as well as being able to gain insights on the FDA’s preferences. In her words, “tone, tenor, and transparency” were the key positive differences.

    According to Garcia-Canton, she noticed that in the beginning, especially, there was a lot of awkwardness between the scientists and the FDA. The idea that the scientists are worried about saying or doing the wrong thing in the FDA’s eyes was iterated by both Garcia-Canton and Stark, but Garcia-Canton emphasized that “this is the place for scientific debate.”

    Stark was asked whether scientists are learning and taking information away from the program. “Change is hard for a lot of people,” Stark said. She noted that there was a lot of confusion over deficiency letters and what was expected from applicants. The FDA’s takeaway, according to Stark, was that it needs to reframe the deficiency letters to better communicate and clear up what the organization needs. She also noted that the scientists, through these communications, are learning that there may be other ways to do things.

    One of the big questions to the panel was whether the FDA made expectations clear from the beginning of the program. Ehrlich was quick to say that they were not entirely clear in the beginning. Garcia-Canton noted that she can sympathize with the FDA reviewers and that both sides can do better with communicating information. “I was not surprised by the request for information,” she said. Adding on to Stark’s notes on deficiency letters, Garcia-Canton noted that she did not always understand what the FDA was asking for and even used AI to ask what the letters meant; she received different answers from different AI programs. However, she noted that she believes the program will help with focus and clarity for future submissions. Rogers Hollins was honest that having gone through it, “I still can’t explain the whole process.” She said that getting more insight would be really helpful and that it would be useful to have more information more easily available in a more informal manner.

    The conversation turned to many of the misperceptions of the pilot program, which Stark cleared up by discussing the theory that the companies in the pilot program are just being pushed through and rubber stamped. She stated that the organization has “not given up on scientific rigor” and that “100% of what was submitted was reviewed” and that the companies heard about any questions that the organization had. Rogers Hollins confirmed that the FDA has been “upholding the scientific standard,” and Garcia-Canton said that the FDA is “keeping up scientific content” and upholding a very high quality.

    An audience member asked if the pilot program is something that can be realistically sustained, to which Stark answered, “Yes, with some changes.” She noted that the FDA needs engaged interaction and increased communication with industry to continue moving forward.

    Another valid question for Stark was what small companies can do to prepare for the submission process. “The standard is the same whether small, medium, or large,” she said. Small businesses may need a little bit more development time or may need to use consultants, though. Stark recommended utilizing the pre-submission review process and meeting with the FDA prior to submissions. Her advice was to plan early, communicate with the FDA, and give time to apply guidance before submission.

    The question of what the biggest challenge is for the existing applicants that are still waiting was asked. Ehrlich stated that applicants “want to know what the noise is—what don’t we need to do?” She also asked whether the wheel needs to be reinvented every time or if there is a way to rely on the existing data for these, very similar, products to help streamline the process. Her takeaway from that question was one of her own: “What is essential and what are the different ways of getting to that, and what is just noise?”

    Stark responded that the FDA is looking at four focused areas for pouches: product characterization, consistent manufacturing, adult benefit, and preventing youth use.

    The panel seemed to agree that the definition of “benefit” in this regard concerns relative risk. Stark noted that she does “not personally agree” with the recent media reports on pouches. The FDA is always concerned about youth access, she said.

    Stark outlined the many meetings with different groups involved in the review of products that help ensure consistency of applications. This also helped to explain part of why the review process takes so long currently. “Is it changing?” she said. “Yes.” She went on to note that “We don’t need to have six meetings a week anymore.” That being said, she emphasized that they are looking over all information and trying to fill in any holes that may exist as they review product applications.

    The panel ended with appreciation of the open conversation and communication. “I’m incredibly excited to be here,” Stark said. “We have a shared effort.” She noted that the pilot program is currently expanding to other programs as well. ENDS is actively progressing, she said. It is no longer a pilot. “We can’t control everything, but we’re looking to learn every step of the way,” Stark said.  

  • FDA Tobacco Chief Highlights Progress, Challenges in Product Reviews and Enforcement

    FDA Tobacco Chief Highlights Progress, Challenges in Product Reviews and Enforcement

    Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products (CTP), sat down for a fireside chat to kick off the second day of the American Tobacco and Nicotine Forum (ATNF) in Leesburg, Va. Christopher Greer, president and CEO of the Nicotine Resource Consortium, led the discussion on behalf of industry leaders eager to hear more about the inner workings of the regulatory agency.

    Koplow said the agency has made significant progress in reducing its backlog of premarket tobacco applications, cutting it by roughly 70% over the past year and eliminating the acceptance queue. He noted that while the FDA has reviewed approximately 27 million applications, only a small number have been authorized, largely because most submissions lacked the scientific data required to demonstrate public health benefits.

    Koplow said the agency is working to improve transparency and guidance for applicants, including plans to share lessons learned from the review process to help companies better meet regulatory standards. He also pointed to efforts to streamline evaluations in certain product categories, such as nicotine pouches, where a pilot program enabled faster authorizations and is expected to inform broader regulatory approaches.

    On enforcement, Koplow highlighted increased action against illicit products, including major seizures of unauthorized e-cigarettes in coordination with federal agencies, with most originating from China. He acknowledged ongoing challenges in balancing harm reduction for adult smokers with youth protection, noting declines in youth vaping but continued concerns about public understanding of nicotine risks and the need for stronger evidence on comparative benefits of alternative products.

  • Articles Accuse Makary of Putting Reputation Over Science

    Articles Accuse Makary of Putting Reputation Over Science

    Over the weekend, multiple sources criticized FDA Commissioner Marty Makary for being influenced by reputational considerations rather than evolving evidence on risk and consumer behavior in the regulation of reduced-harm nicotine products. According to The Wall Street Journal, tensions have emerged between the White House and the FDA, with the administration pushing to expand access to flavored vaping products while Makary has blocked authorizations despite internal scientific support. The report cited a case involving vape company Glas, where FDA scientists recommended approval of several flavors, but a memo from Makary’s office delayed the decision, highlighting a divergence between scientific review and agency leadership.

    Separately, Brownstone Institute published an article by Roger Bate arguing that regulatory progress on reduced-risk nicotine products has stalled despite declining youth vaping rates and evidence supporting harm reduction. Bate wrote that approvals for products such as vapes and nicotine pouches have slowed significantly, and wrote that “reputable sources” attributed this in part to Makary’s reluctance to act, citing concerns within the agency that decisions are being shaped by reputational risk rather than scientific data.

  • FDA Renews Modified Status for IQOS Products

    FDA Renews Modified Status for IQOS Products

    The U.S. Food and Drug Administration has renewed modified risk tobacco product (MRTP) orders for several Philip Morris International IQOS devices and HeatSticks consumables, allowing the company to continue marketing the products with reduced-exposure claims. The authorization covers two IQOS device systems and three HeatStick variants, with the FDA reaffirming that available scientific evidence supports claims that switching completely from cigarettes to IQOS can significantly reduce exposure to harmful chemicals.

    The products receiving modified risk granted orders are IQOS 2.4 system, IQOS 3.0 system, Marlboro Amber HeatSticks (previously Marlboro HeatSticks), Marlboro Green Menthol HeatSticks (previously Marlboro Smooth Menthol HeatSticks), and Marlboro Blue Menthol HeatSticks (previously Marlboro Fresh Menthol HeatSticks).

    The agency said its latest review found new data consistent with earlier findings from initial approvals granted between 2019 and 2022. Under the renewed orders, Philip Morris can state that the IQOS system heats rather than burns tobacco, resulting in lower production of harmful substances. However, the FDA emphasized that the designation does not mean the products are safe or approved, and it restricts the company from making broader health or risk-reduction claims beyond those explicitly authorized.

    The renewed MRTP status is subject to ongoing regulatory oversight, including requirements for postmarket surveillance to monitor consumer behavior and public health impact. The FDA retains the authority to withdraw the authorization if the products no longer demonstrate a net benefit to population health.

  • FDA Releases Wave 8 PATH Study Data

    FDA Releases Wave 8 PATH Study Data

    New Wave 8 Restricted-Use Files from the Population Assessment of Tobacco and Health (PATH) Study are now available from FDA’s Center for Tobacco Products and NIH’s National Institute on Drug Abuse. The PATH Study is a household-based, nationally representative, longitudinal study of adults and youth (12-17 years old) in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act.

    These Wave 8 files contain data collected between January 2024 and December 2024, including questionnaire data, location characteristics data, and state identifier data. The PATH Study Restricted-Use Files have been updated to include tobacco product Universal Product Code data and Ever/Never reference data for all participants with updated Master Linkage Files. Researchers are encouraged to submit a request to obtain access.

    In addition to these newly released data files, researchers may also request access to all currently available Biomarker Restricted-Use Files. Data and documentation from the Public-Use Files are also available for download with updated Master Linkage Files.

    Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com.

  • Judge Issues Final Ruling on Decade-Long ‘Premium Cigar’ Definition

    Judge Issues Final Ruling on Decade-Long ‘Premium Cigar’ Definition

    A U.S. federal court in Washington, D.C., issued what is said was “hopefully” a final ruling, vacating the FDA’s 2016 Deeming Rule as it applies to premium cigars, marking the conclusion of a decade-long legal battle over the agency’s authority. Judge Amit P. Mehta reaffirmed that premium cigars — defined by criteria such as being handmade, composed of natural tobacco, and free from characterizing flavors — should be treated as a distinct category and excluded from the broader regulatory framework applied to other tobacco products. The decision follows earlier rulings in 2023 and subsequent appellate review, which required the court to revisit and finalize the definition of “premium cigars.”

    The court ultimately upheld its original eight-point definition, rejecting industry proposals to loosen certain requirements and agreeing with the FDA that any refinements should be addressed through formal rulemaking rather than judicial changes. The ruling provides regulatory clarity and removes premium cigars from key FDA oversight requirements, while leaving open the possibility of future changes through the agency’s policymaking process.

    Industry groups welcomed the outcome as a major victory. The Cigar Rights of America (CRA) said the ruling confirms long-standing arguments that premium cigars differ fundamentally from mass-market tobacco products, with Executive Director Mike Copperman calling it “long-overdue clarity” after years of advocacy. Similarly, the Premium Cigar Association (PCA) said the decision brings needed certainty for manufacturers, retailers, and consumers, with CEO Joshua Habursky emphasizing that the outcome recognizes premium cigars as a distinct category warranting separate regulatory treatment.

    The Cigar Association of America (CAA), which previously opposed parts of the ruling not because it disagreed with the exemption itself but because it sought a broader and more flexible definition of what qualifies as a “premium cigar,” did not return a request for comment.

  • PM Urges Court to Uphold FDA Graphic Rule Ruling  

    PM Urges Court to Uphold FDA Graphic Rule Ruling  

    Philip Morris USA asked the U.S. Court of Appeals for the Eleventh Circuit to affirm a lower court decision vacating a U.S. Food and Drug Administration rule that would have required graphic health warnings on cigarette packaging. The company argued that the district court correctly found the FDA failed to follow required administrative procedures when developing the rule. According to Law 360, the appeal centers on whether the agency’s rulemaking process complied with federal standards, after the district court struck down the regulation on procedural grounds.